Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
Closed Posted
- Opportunity number
- RFA-FD-25-001
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications due
- Award size
- Up to $650,000
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- Tribal Governments (Federally Recognized)
- County Governments
- 501(c)(3) Nonprofits
- Non-501(c)(3) Nonprofits
- Tribal Organizations (Not Federally Recognized)
- Public or Indian Housing Auth.
- Small Businesses
- For Profit Organizations
- State Governments
- Independent School Districts
- Unrestricted
- Higher Education Inst. (Public)
- Higher Education Inst. (Private)
- City/Township Governments
- Special District Governments
- Full announcement
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Department of Health and Human Services Food and Drug Administration (FDA) is seeking applicants for the "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required" funding opportunity. This grant aims to support clinical trials of products evaluating efficacy and/or safety in addressing unmet needs for rare neurodegenerative diseases in children and adults. The agency expects this effort to increase the number of approved treatments for rare neurodegenerative diseases and have a positive impact on rare disease drug development. Eligible applicant types include tribal governments, nonprofits, small businesses, and higher education institutions, among others. The proposal due date is October 21, 2025.
Recent awards under the Food and Drug Administration Research program, which funds this opportunity, have ranged from approximately $200,000 to over $3 million and typically span 1-4 year project periods. The work is expected to be performed at the recipients' facilities, though some projects may involve collaboration with the FDA or other sites.
Synopsis
The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.
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